BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    gammaCore Sapphire

    DI: 00815203020133 · Model: 10016-40303 · ELECTROCORE, LLC
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    gammaCore Sapphire
    Primary DI
    00815203020133
    Version / Model
    10016-40303
    Catalog Number
    10016-40303
    Company Name
    ELECTROCORE, LLC
    Labeler DUNS
    831341628
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-04-06
    Public Version
    3
    Public Version Date
    2020-05-21
    Public Version Status
    Update
    Public Device Record Key
    c0e4d06b-9b81-4696-b2fe-89793ec8bea6

    Device Description

    gammaCore Sapphire, part number 10016-40303, is a multi-use, hand-held, rechargeable, portable device consisting of a rechargeable battery, signal generating and amplifying electronics, with a slide control switch for user / operator control of the signal amplitude. It includes a charging station incorporated into the “clam shell” storage case connected to a power adapter to charge the device as necessary by the end user. It can be programmed to deliver up to 30 doses per day for 93 days and can be refilled / reloaded for additional 10, 31, or 93 day periods via a "Refill Card" encoded and provided by electroCore or its authorized agent. (Once the maximum daily number of doses has been reached, the device will not deliver any more doses until the following 24-hour period.) The Refill Card will be provided to the user / patient requesting a refill of their device, along with one to six additional tubes of conductive gel (number of tubes provided is based on the 10, 31, or 93 day refill being provided). On receipt of the Refill Card, the user refills the gammaCore device by placing the Card across the face of the device (with the device turned on). The device will display “rd” and the "refill" icon as the device reads the Card. The device will signal (beeping twice) when it has been loaded with the programmed doses. The device is now ready to be used for treatment. Each Refill Card can only be used for one refill; upon completion of the device refill the card may be thrown away. A manufacturer accessible only Bluetooth feature is enabled to facilitate device diagnostics of any devices returned to the manufacturer to allow a review of the number of days the device was used, number of doses provided, and any days / doses yet remaining on a device.

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    MR Unsafe
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    Yes
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    PKR Non-Invasive Vagus Nerve Stimulator - Headache
    QAK Non-Invasive Vagus Nerve Stimulator For Migraine Headache

    GMDN Terms

    Code Name
    58832 Migraine-therapy peripheral nerve electrical stimulator

    Identifiers

    Type ID
    Primary 00815203020133

    Customer Contacts

    Phone
    1-888-903-2673
    Email
    [email protected]

    Storage Conditions

    Type
    Special Storage Condition, Specify
    Special Conditions
    Replace protective cover after use to protect the treatment surfaces from damage.
    Type
    Handling Environment Temperature
    Temperature Range
    0 – 38 Degrees Celsius
    Type
    Handling Environment Humidity
    Temperature Range
    10 – 90 Percent (%) Relative Humidity
    Type
    Storage Environment Temperature
    Temperature Range
    0 – 38 Degrees Celsius
    Type
    Storage Environment Humidity
    Temperature Range
    10 – 90 Percent (%) Relative Humidity
    Type
    Storage Environment Atmospheric Pressure
    Temperature Range
    – 80 KiloPascal
    Type
    Handling Environment Atmospheric Pressure
    Temperature Range
    – 80 KiloPascal